Angela D. Ritter, M.D. – 681999

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 24-HFD-45-06-01 Product: Drugs Recipient: Angela D. Ritter, M.D. 2350 Limestone Parkway NEGainesville, GA 30501-2013United States Issuing Office: Center for Drug Evaluation and Research | CDER...

Update: COVID-19 Vaccine Booster Composition

June 30, 2022FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) held a virtual meeting on June 28, 2022, to publicly discuss whether a change to the current vaccine strain composition of COVID-19 vaccine booster doses is necessary for the 2022...

Aqualex Co., Ltd. – 672292

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Gee Ho Jang Aqualex Co., Ltd. RM 203, 27, Dunchon-Daero 457beon-GilJungwon-guSeongnam-siGyeonggi-do13219South Korea jangnoru@aqualex.co.kr Issuing Office: Center for Drug Evaluation and Research | CDER...

CBER’s Patient Engagement Program

Your organization’s activities, for exampleNatural history studiesPatient-reported outcomes studiesPatient surveys on risks, benefits, and preferences related to treatmentsImpact of the disease and its treatmentChief complaints (most bothersome signs and...

HIZENTRA

STN:  BLS 125350Proper Name: Immune Globulin Subcutaneous (Human), 20% LiquidTradename: HIZENTRAManufacturer: CSL Behring AGIndication:Indicated for the treatment of:Primary immunodeficiency (PI) in adults and pediatric patients 2 years of age and older.Maintenance...

SHINGRIX

STN: 125614Proper Name: Zoster Vaccine Recombinant, AdjuvantedTradename: SHINGRIXManufacturer: GlaxoSmithKline Biologicals, S.A.Indication:SHINGRIX is a vaccine indicated for Prevention of herpes zoster (HZ) (shingles):In adults aged 50 years and older.In adults aged...

Prescription Drug Marketing Act of 1987

The Prescription Drug Marketing Act of 1987 (PDMA) was signed into law by the President on April 22, 1988. The PDMA was enacted (1) to ensure that drug products purchased by consumers are safe and effective, and (2) to avoid the unacceptable risk to American consumers...